To prevent injury or damage to the system, do not modify the equipment. Patients should be aware that during skydiving, the sudden jerking that occurs when the parachute opens may cause lead dislodgement or fractures, which may require surgery to repair or replace the lead. Lead movement. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. Operation of machinery and equipment. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. It is extremely important to select patients appropriately for neurostimulation. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Extension of the upper torso or neck may cause lead movement and alter the stimulation field (especially with leads in the cervical area), resulting in overstimulation or ineffective stimulation. Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics and induce voltage through the lead that could jolt or shock the patient. Securing the lead with the lead stabilizer will mitigate this risk. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . Back pain. Extension of the upper torso or neck may cause lead movement and alter the stimulation field (especially with leads in the cervical area), resulting in overstimulation or ineffective stimulation. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. Make the Bold Choice Pregnancy and nursing. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Do not use the application if the operating system is compromised (that is, jailbroken). Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Therapeutic magnets. During the implant procedure, if an electrosurgery device must be used, take the following actions:. In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this neurostimulation system: Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs; if either occurs, turn off your IPG immediately, Undesirable changes in stimulation, which may be related to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections, or lead failure, Persistent pain at the electrode or IPG site, Seroma (mass or swelling) at the IPG site. Surgical advice for removal. During the 2000s about a dozen companies sold and manufactured SCS systems worldwide, including the "big three" (Boston Scientific, Abbott/St. Equipment is not serviceable by the customer. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers Expanded MRI Compatibility in U.S. - New U.S. FDA-approved labeling lifts restrictions on 60-centimeter Octrode leads,. Failure to do so may result in difficulty delivering the lead. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. away from the generator and avoid placing any smart device in a pocket near the generator. The placement of the leads involves some risk, as with any surgical procedure. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. Infection. Patient training. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. Patient's mental capacity, as patients with cognitive impairment or those prone to developing dementia would likely have difficulty performing device-related tasks without assistance. Overcommunicating with the IPG. Follow proper infection control procedures. Needle insertion. Output power below 80 W is recommended for all activations. If they must go through a gate or doorway containing this type of device, patients should turn off their IPG and proceed with caution, being sure to move through the device quickly. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. Lead inspection. To prevent unintended stimulation, do not modify the generator software in any way. The operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death. Case damage. Lead damage from tools. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief. Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. 2013;16(5):471-482. away from the generator and avoid placing any smart device in a pocket near the generator. Activities requiring excessive twisting or stretching. The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation. commercial electrical equipment (such as arc welders and induction furnaces). Advise patients who experience these types of stimulation changes to turn down the amplitude or turn off the IPG before making extreme posture changes or abrupt movements such as stretching, lifting their arms over their heads, or exercising. High stimulation outputs. Pregnancy and nursing. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Radiofrequency or microwave ablation. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death. Preventing infection. Patients should exercise reasonable caution when participating in activities that require coordination, including those that they were able to perform prior to receiving DBS therapy (for example, swimming). Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Undesirable changes in stimulation, which may be related to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections, or lead failure. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for six to eight weeks after implantation of a neurostimulation system. A multicenter, prospective trial to assess the safety and performance of the spinal modulation dorsal root ganglion neurostimulator system in the treatment of chronic pain. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or render the patient incapable of controlling the generator. Set the electrosurgery device to the lowest possible energy setting. For more information, see the clinician programmer manual. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. This neurostimulation system is indicated for spinal column stimulation via epidural and intraspinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with complex regional pain syndrome (CRPS) types I and II.**. Infection. Follow proper infection control procedures. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. If needed, return the equipment to Abbott Medical for service. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. Excessive lead migration may require reoperation to replace the leads. Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. Use extreme care when removing the lead stylet, the delivery sheath, and the needle to ensure that the distal tip of the lead remains in the desired location. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. System testing. If two systems are implanted, ensure that at least 20 cm (8 in.) Return all explanted components to Abbott Medical for safe disposal. This may occur once the lead is in place and is connected to the neurostimulator and activated. Safety and effectiveness of neurostimulation for pediatric use have not been established. Do not use excessive pressure when injecting through the sheath. Do not place the IPG deeper than 4.0 cm (1.57 in) because the clinician programmer or patient controller may not communicate effectively with the IPG. Placing the IPG. Wireless communications equipment, such as mobile and cordless phones and walkie-talkies, may interfere with the IPG if the equipment gets too close to the IPG. Component disposal. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves. If radiation therapy is required, the area over the implanted generator should be shielded with lead. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. Do not implant a device if the sterile package, the device, or any device components show signs of damage, tampering, or if the sterile seal is ruptured, or contamination is suspected for any reason.